CA 02404653 2002-10-09
WO 01/76403 PCT/US00/09529
PROTECTIVE CUSHION AND COOPERATIVELY
ENGAGEABLE HELMET CASING FOR ANESTHETIZED PATIENT
BACKGROUND OF THE INVENTION
6
1. Field of the Invention
The present invention relates to a safety helmet for
cranial protection. More particularly it relates to a modular
helmet apparatus constructed of interchanging cooperative
11 components of differing sizes which provide a prophylactic
cushion and helmet to be worn by patients undergoing general
anesthesia to prevent eye, skin, or other nerve damage from
prolonged pressure upon areas of the head as well as to
provide a safer manner for cranial manipulation during
16 surgery.
2. Prior Art
Surgeries upon patients in the prone position present a
number of patient care challenges to the anesthesiologist and
surgical staff. Once a patient undergoing a surgery requiring
21 general anesthesia is anesthetized, that patient is
essentially in a coma like state. In such a state, noxious
stimuli to the patient's body and skin, such as pressure or
pain, which would normally cause an awake patient to move to
relieve the stimulus, no longer causes such a reaction.
26 Consequently, patients under general anesthesia are especially
threatened by a number of factors, other than the surgery
itself, which arise during such surgical procedures.
WO 01l7(i403 PCTIUS00l09529
One hazard which requires constant vigilance by the
surgical staff to protect against injury is the threat of eye
damage. Inadvertent pressure upon the ocular structures of a
patient for just a matter of minutes can cause extreme damage
or blindness to the eye. As noted above, because the
6 anesthetized patient is in a coma like state, the discomfort
of facial compression upon the eye, which would normally cause
an awake patient to'move and relieve that pressure, fails to
alert the anesthetized patient. Care must be taken by an ever
alert surgical staff to inspect for possible pressure points
11 about the ocular structures of the patient and to move the
patient's face to prevent eye damage.
~
Other compression injuries can occur to the anesthetized
patent's forehead and chin areas. Here again, the constant
pressure upon those areas, caused by the weight of the
16 patients own head, if not relieved by movement of the face to
allow blood flow thereto, can cause localized ischemia to the
chin and forehead area. Since the anesthetized patient does
not react to the body's cues of discomfort preceding injury,
the risk of harm in a matter of minutes to these areas is
21 great.
An additional concern during surgical procedures of the
anesthetized patient is the decrease in body temperature that
can occur during surgery. Currently bulky warmed towels and
electric blankets are used in an attempt to warm the patient.
26 Such endeavors crowd the operating field and are not easily
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Wo Ol/76403 PCT/US00/09529
1 controlled for temperature.
Currently, there are a number of conventional methods to
support the head and protect the eyes and face of a patient
from compression injuries during surgery which require the
patient to be placed in a prone, face down, position for the
6 long periods of time involved in surgery. One method
conventionally used is placement of the patient's head and
face in a horseshoe shaped frame supporting a foam pillow
which holds the patients face off of the operating table in a
supported manner. The patient's eyes are generally taped shut
11 when such a structure is used to keep them from contact with
the foam and to prevent eye fluid drainage. This frame and
pillow support however has inherent hazards of its own in that
it cannot distribute pressure maximally over the surface of
the head. Further, great care must be taken by the
16 anesthesiologist and staff to make sure that any anesthetic
equipment, such as endotracheal tubes, esophageal
stethoscopes, or electronic sensing devices, are not dislodged
or disrupted by gravity or patient positioning during the term
of the surgical procedure. Such disruption or dislodgement of
21 surgical equipment can cut off the air supply to the patient
or lead to inaccurate readings by monitoring equipment.
Another method is simply to place the patient's face
sideways on a pillow or towel located upon the surgical table.
However, this method suffers from the danger of tubing
26 collapse due to the patient's head weight, and even a face or
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WO 01/76403 PCT/tIS00/09529
1 eye supported by a foam pillow may be damaged if the pressure
is uneven and remains on one area too long. Further, the
placement of the patient's face on a towel requires the head
to be turned one way or the other, placing pressure on one
side of the face which, as noted earlier, subjects the patient
6 to the potential of injury. Additionally, blood flow through
the veins and arteries of the neck may be impaired by this
twisted fashion of head support. Hazards to the patient
increase if the surgery requires a face down posture because
the danger of tube collapse from pressure or bending increases
11 with the tubes entering the patient's body through the mouth
or nose being compressed between the patient's face and the
operating table. With the entry points to the head out of
view, such constrictions of the tubes also remain out of
sight.
16 A further challenge facing surgical teams during surgery
on anesthetized patients is the seemingly simple task of
rolling the patient over from a supine position to a prone
position on the operating table or from a cart onto the
operating table. Generally, the patient at this point in the
21 surgical procedure is already intubated, asleep, and basically
"dead weight." In this physical state, the patient is at
great risk of injury during the roll over procedure,
especially to the neck area. Additionally vexing to the
surgical staff is the fact that the patient, with tubes
26 exiting the mouth and/or nose, must be rolled over, without
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WO 01/76403 PCT/US00/09529
1 disturbing the tubes and without injuring the neck.
Concurrently during the roll over procedure, the surgical
staff must plan ahead so that when the patient is placed face
down on an operating table, the face is properly aligned with,
and inserted upon or into the pillow, already located upon the
6 table. This insertion of the face into the pillow is
conventionally done without the benefit of a pre surgery fit
to make sure the face and pillow and frame mate in a manner
that will accommodate the patient for the term of the surgery
and protect the face from compression injury. Heads and
11 faces being quite different amongst people in general, an
optimum fit between face and pillow is achieved only a small
percentage of the time. Once in this prone position, the
4.
danger of injury remains constant and continued and consistent N
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vigilance by the surgical staff is required to ascertain, that o
16 in fact, the patient's airways are open, the eyes are not
compressed, and the face is not being subjected to pressure at
any point for a duration sufficient to cause nerve damage.
Finally, when the operation is over, the patient must
again be moved off of the operating table and is generally
21 rolled over onto a gurney in a reverse roll over procedure.
Still anesthetized, the patient is at great risk of injury to
the neck if the head is not adequately supported and
manipulated during this roll over process.
Still further, if an emergency develops while the patient
26 is in the face down prone position, requiring the patient to
WO 01/76403 PCT/LTS00/09529
1 be rolled to the supine position, valuable life saving time
can be lost trying to upright the patient without injury to
the neck, and without crimping the airway supply tubing and
monitoring equipment communicating through the nose and mouth
of the patient.
6 Further, patient size is also a factor in the fitting of
facial and head support. A child may have a very small face
and head and an adult a large one. Conversely, a large child
may have a head and face requiring support in areas much
different from a small stature adult.
11 U.S. Patent 5,220,699 (Farris) teaches an inflatable
pillow mounted inside a mask for variable support of differing
sized patients. However Farris requires the use of an
inflatable chamber which as taught is inflated once the
patient has already been rolled to the prone position. It
16 requires an air inflation device to function and lacks the
ability for an easy installation prior to surgery and will not
function without compressed air.
U.S. Patent 4,400,820 (O'Dell) teaches an apparatus using
pads and having a"T" shaped void which may be used in
21 combination with a support structure to hold the patient's
head. However, O'Dell does not allow for pre-fitting and pre-
installing the protective device prior to surgery and does not
aid in protecting the patient during roll over on and off the
table.
26
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WO 01/76403 PCT/USOO/09529
1 U.S. Patent 5,214,815 (Agbodoe) teaches a surgical
headrest with a removable foam pad; however, Agbodoe does not
provide any manner to pre-fit and install the device on the
patient prior to being asleep and it mounts to the table and
is intended for use after roll over thereon.
6 U.S. Patent 4,757,983 (Ray) features a pair of cushions
attached to a horseshoe-shaped frame for surgical head
support. However Ray also suffers from an inability to pre-fit
and install the device on patients prior to surgery while they
are awake as well as lacking any protective ability during
11 dangerous roll over onto the table and like the=aforementioned
prior art, lacks the ability to see the patient's eyes and
face from the side or from above. ~
As such, there exists a need for a support device that is N
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easily modified to fit a variety of patients of differing
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16 size, and that may be pre-fit to the patient prior to surgery
while the patient is alert and able to ascertain the comfort
or discomfort level of the device. Further such a device
should provide an additional manner'to support the head and
maximally diffuse pressure over a large area while helping
21 prevent patient thermal heat loss during surgery, as well as
during the hazardous movement of the patient prior to and
after surgery. Such a device should also provide for easy
viewing of the patient's eyes and nose from a side and top
view during the operative procedure so that the patient may be
26 continually monitored by the staff.
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WO 01176403 PCTIIISOO/09524
1 A further need exists for such a device that may be
cooperatively engaged with a positionable mount or used by
itself if needed yet still provide a view of the eyes and
ocul,ar area of the patient from looking inward from the side.
6 SUMHARY OF THE INVENTION
The present invention relates to a new and improved
protective helmet apparatus which provided functionally
through the ability to vary the configuration for the physical
characteristics of patients undergoing general anesthesia
11 during surgery, and provide optimum cranial support to the
patent using differing configurations of the various parts of
the device. Concurrently, the device, when using a 0
Ln
substantially transparent helmet casing and operatively placed
apertures provides the medical professionals operating on the
16 patient, easy viewing of the patients facial features and easy
access to the nasal and oral passages of the patient in either
the prone or supine position. The device is best made of
modular construction allowing for the substantially
transparent helmet casing to fit a variety of different sized
21 patients. Interchangeable and replaceable cushions of
variable dimensions on one surface to accommodate different
patient facial structures are positionaable in a plurality of
interchangeable light weight helmet casings. The cushions on
their exterior surface are dimensioned for a registered fit
26 with the helmet casing surface and apertures in the.cushion
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WO 01/76403 PCT/IJSOO/09529
1 register with apertures in the helmet casing. The cushions
can also be color coded to designate different sizes to
accommodate different sized patients. If desired, while not
the best mode for maximum support and positioning, the
cushions themselves can be used without the helmet casing, yet
6 still provide a side view of the patient's eyes and temple
area during the procedure through an aperture communicating
through a sidewall to the face of the patient. Such might be
the case in emergencies when sufficient helmet casings are not
available or when a low mount of the patient's head is
11 desirable.
The device is especially useful in that it allows for
pre-fitting of the patient while the patient is awake and
alert using modular pads of differing facial dimensions and
having a rear or mask.side dimension configured to fit into a
16 registered position in the helmet casing. While the current
best mode combines the proper sized cushion with the
appropriate helmet casing for a mount on the table surface,
even using the facial cushion by itself, if desired, yields a
substantial increase in utility over prior art due to the
21 viewing of the patient's eyes and temple area from the side
afforded by the apertures therefor. The device having the
pre-fitted cushions or pads mounted into the helmet casing,
and featuring appropriate indentations on the facial contact
surface, evenly diffuses pressures on the face of the wearer
26 and may be worn into surgery such that the surgical team need
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WO 01/76103 PCTNS0O/09529
1 not worry about trying to fit the patient with pillows or pads
in a table mounted frames after the patient is asleep.
For use in a variety of patients in prone or supine
positions during surgery the various embodiments of the device
offer a plurality of ways in which to support the patient's
6 head. One embodiment features a hinged or optionally
removable lower chin support which is moveable from a first
position in operable contact with the helmet casing to a
second position out of such contact, thus allowing the
surgical team e.asy access to the entire face and mouth area
11 for insertion of required tubing into the patients mouth
andlor nose. The chin support is thereafter reinstalled to
provide lower chin support with the entire helmet being worn
by the patient for the rollover procedure on and off the table
to protect the patient from injury during the course of the
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16 surgical procedure. Or, the chin support may be provided by o
the cushion itself with the cushion and the helmet casing w
extending below the mouth area of the patient thus eliminating
the detachable chin support.
As the device may be pre-fitted for optimal weight
21 diffusion and comfort and can be worn during the movement of
the patient on and off the operating table, the surgical team
is relieved on concerns of whether the device to hold the.face
and head actually fits the patient. Further, an optional
rotating handle upon the top of the helmet provides a handy
26 gripping point for the head for the surgical team to help
WO 01/7(i303 PCTIUSOO/09529
1 prevent neck injury during roll over of the patient on and off
the table. By placement of a hand on the face of the mask and
another on the rotating handle, smooth and continual support
may be provided to the neck and head area when the patient is
being rolled over on or off of the operating table.
6 Another embodiment of the device features a helmet
casing, which is best made of substantially transparent
material, having an interior cavity that is formed to register
with a cooperatively engageable cushion. The cushion is made
from foam or other soft resilient material and is dimensioned
11 on one surface to accommodate the patient's face, and on the
other opposite or exterior surface, to register with the
interior cavity of the helmet casing. A raised border about
the exterior surface perimeter of the cushion could be formed
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during manufacture to provide an additional means to register
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16 and align the cushion with the openings in the helmet casing.
Optionally, the cushions may be color coded for patient facial
sizing. one or a plurality of apertures communicating through
the helmet casing register with appropriately configured
apertures communicating between the two surfaces of the
21 cushion and provide an in line cavity from the patient's face
through the casing. This in-line cavity provides access to
the patient's mouth, nose, and eyes. By dimensioning the
cavity to extend around the patients face at eye level, easy
viewing of the patient's eyes and nose is provided to the
26 operating room staff.
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WO 01/76403 PCT/LISQO/Q9529
1 An additional embodiment of the device would feature a
plurality of legs on the exterior surface of the helmet casing
to provide a raised mount above the operating table. The legs
can be adjustable for height above the operating table to
provide comfortable posture to the patient while affording the
6 best access and view of the face of the patient to the staff
of the operating room.
In the current best mode, an optional base may also be
provided which provides a releasable but solid mount for the
helmet casing using cooperating fasteners located on the mount
11 and the exterior of the helmet casing. The mount acts as a
positioner by providing a stable mount for the helmet casing
and optionally may provide additional utility in the best mode
with a surface mounted mirror for providing a reflective view
of the patient's eyes and nose to the staff of the operating
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16 room while the patient is face down and the staff is
substantially in an upright position. This eliminates the
constant need for members of the operating team to bend over
to inspect the face and eyes of the patient during surgery in
providing a continuous view of the eyes and face of the face-
21 down patient. Additional utility is provided by an optional
light means positioned on the upper surface of the mount
adjacent to the mirror by illuminating the patient's face
through the in-line cavity and enlightening the reflection on
the mirror for the staff to more easily view it from a
26 distance.
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WO 01/76403 PCT/US00/09529
1 An object of this invention is to provide a helmet which
prevents injury due to ocular compression during surgery by
minimizing ischemic damages through maximal diffusion of
pressure about the patient's head.
I Another object of this invention is the provision of a
6 protective device for use during surgery which allows for pre-
fit of the patient prior to surgery while the patient may
comment on the comfort or discomfort level of the device.
A further object of this invention is to provide a
protective helmet for surgery which provides a facial and chin
11 support to the patient which is easily removable by the
surgical team for insertion of required devices into the mouth
and nose of patient and thereafter easily reinstalled.
An additional object of this invention is the allowance N
of easy access to and viewing of, the patients eyes and temple o
16 area through apertures in the device positioned to
accommodate such access and viewing.
Another object of this invention is the provision of a
protective surgical helmet of modular construction which
allows for positioning of different sized facial cushions and
21 components into the helmet casing to accommodate the head
different sized patients.
An additional object of this invention is providing an
easily sterilized protective helmet through the use of easily
sterilized cushions or inexpensive throw away insertable
26 cushions removably mountable inside an easily sterilized or
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WO 01/76403 PCT/[IS00/09529
1 cleaned helmet shell.
A still further object of this invention is to
concurrently provide easy viewing of the eyes and mouth area
of the patient while the device is mounted upon the patient.
, A still further object of the invention is the provision
6 of the ability to control and alter the temperature of the
device to aid in temperature control of the patient during
surgery.
An additional object of this invention is to provide easy
viewing of the patients facial features to the operating staff
11 using while concurrently allows the staff members to remain
substantially upright through the provision of a reflective
means of the face of the patient.
Further objects of the invention will be brought out in
the following part of the specification, wherein detailed
16 description is for the purpose of fully disclosing the
invention without placing limitations thereon. ~O
BRIEF DESCRIPTION OF DRAWING FIGURES
Figure 1 is a perspective frontal view of the protective
21 helmet device showing the chin support in a mounted position.
Figure 2 is a frontal view of the device featuring the
hinged repositionable chin support_
Figure 3 is a rear exploded view of the protective helmet
device showing the modular pads for the ocular area and chin
26 support.
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1 Figure 4 shows the helmet with detachable and
repositionable chin suppbrt portion.
Figure 5 depicts the helmet with detachable and
repositionable chin support slidably mountable to the helmet.
, Figure 6 depicts a side view of the apparatus showing the
6 optional handle side grip and the flat face for secure
positioning on the surgery table.
Figure 7 depicts another embodiment of the device
featuring an exploded view a helmet casing of unitary
construction with insertable modular pad providing facial and
11 chin support in a single combined unit.
Figure 8 depicts the helmet casing of figure 7 in a
registered position removably or otherwise attached to a mount
with optionally mirrored surface for reflection of the
patient's face therein.
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16 Figure 9 is a top perspective view of the facial cushion
showing the facial indentation and apertures therethrough.
Figure 10 depicts and end cut away view of the facial
cushion for removable mounting to the helmet casing showing
the facial indentation formed to accommodate patient facial
21 structures therein, and the lip for registration with the
casing edge.
Figure 11 depicts a bottom perspective view of the helmet
casing showing the unitary construction and the legs affixed
to the exterior which provide an elevated mount along with the
26 communicating aperture through the casing.
WO 01/76403 PCTlUS00l09529
1 Figure 12 depicts a top view of the mounting base for the
helmet casing with a surface mounted mirror and light source.
Figure 13 depicts a side view of the mounting plate with
a mirror and cooperatively engageable mounts on the upper
surface.
6 Figure 14 is a top view of the upper surface of the
mounting plate showing the mirror and mounts.
Figure 15 is a tope view of the removably attachable
heating blanket with temperature control and clip.
11 DETAILED DESCRIPTION OF THE PREFERRED
ffi48ODI1ENTS OF T8E INVENTION
Referring now to the drawings, Figure 1 depicts a
preferred embodiment of the modularly assembled protective
surgical helmet apparatus 10 featuring the helmet casing 12
16 which is best made from a substantially rigid but easily
molded material such as plastic. The plastic casing should
also be resistant to the heat or chemicals sufficient to allow
for sterilization between uses. The modular version of the
helmet casing 12 mates with a chin support 14 using
21 conventional registering mating positioners such as
registration pins 16 which correspond to apertures 18 upon the
helmet casing 12. 0f course the registration pins 16 and
apertures 18 might be reversed in positioning or other
conventional means of registration and dismountable attachment
26 may be used to achieve a properly aligned mounting of the chin
16
WO 01l76403 PCT/USOO/09529
1 support 14 to the helmet casing 12. Alternatively, the chin
support 14 can be slidably mounted to the helmet casing 12
using a cooperating pair of slide mounts 53 and 51 depicted in
figure 5 wherein the chin support 14 with one half of the
fastener slid mount 53 would be lined up with the helmet
6 casing 12 and cooperating slide mounts 51 and 53 and thereupon
the chin support 14 would slide onto the helmet casing 12 by
pushing it into position and interfacing the cooperating slide
mounts 51 and 53. Cooperating fasteners 20 and 22 in the two-
piece embodiment, such as hook and loop fabric, are used to
11 maintain the chin support 14 in operative contact in a first
position wherein it is in a removably fixed position upon the
helmet casing 12, however, other conventional mating fasteners
at
such as plastic or metal releasable locking fasteners can also
be used and are anticipated. Cooperating fasteners 20 and 22
16 would also be used to maintain the hinged chin support 14 and
slidable chin support 14 in the first position of operable and
registered contact with the helmet casing 12 although in the
case of the slidable version friction alone in the cooperating
slides may be sufficient to releasably hold the chin support
21 14 in proper contact with the helmet casing 12.
The dismountable chin support 14 may also be attached to
the helmet casing 12 at one end using a conventional metal or
plastic hinge fastener 34 such that the chin support 14 will
swing away from its first position in operative contact in a
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WO 01/76403 PCT/[iSQO/09529
1 registered mounting with the helmet casing 12. This
embodiment allows for easy access to the patient's facial area
during surgery or emergencies while mai.ntaining the chin
support attached to the helmet casing 12 when swung to the
second position out of operative contact with the helmet
6 casing so as to avoid loss of the chin support 14.
Straps 24 having cooperating fasteners 25 at their distal
ends securable to mating cooperating fasteners 25a upon the
helmet casing 12 may be optionally used to secure the helmet
casing 12 upon the face of the patient once the properly sized
11 ocular cushion 26 has been removably mounted into the helmet
casing 12.
In certain instances the helmet casing and chin support
might also be formed as one piece for surgeries where a
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removal of the chin support 14 is not a major consideration N
16 and for ease of use and reduction in parts to inventory. In
such a one piece embodiment the support to the face of the
patient provided by the ocular cushion 26 and chin cushion 28
would be provided by a single once piece facial cushion 31
which is configured to removably mount into a one piece
21 embodiment of the helmet casing 12 in a registered position,
therein thereby providing stable even support the entire face
of the patient from forehead to chin. In the one piece
version of the helmet casing 12 the front surface would be
extended to a point below the chin and thereby accommodate a
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WO 01176403 PCT/(IS00/09529
1 once piece facial cushion 31 and apply complete support to the
head of a patient.
The ocular cushion 26 and chin cushion 28, or one piece
facial cushion 31, if reusable, are best made of a closed cell
foam material or other cushioning material which does not
6 absorb fluid easily to allow the cushions to be sterilized in
the conventional fashion for reuse. In many instances
sterilization may not be necessary and a simple washing may
provide the required level of cleanliness. In such cases the
material used will be durable for reuse and resistant to
11 cleaning to allow multiple uses of the cushions 26, 28, or 31.
However, for ease of use and to maintain a highly sterile
field about the patient, disposable ocular cushions 26, chin
= o
cushions 28, and one piece facial cushions 31 may be more
desirable since they could be used once and replaced after o
16 each operation to maintain a highly sterile or sufficiently
clean field. The best mode as to disposable or reusable is
best determined by the criteria of the hospital or surgery
center involved and their individual criteria.
Optionally, for an even more custom fit to individual
21 patients is desirable, the ocular cushion 26 and chin cushion
28 or the once piece facial cushion 31 may also be made
inflatable with gas or fluid or silicone or other gel such
that they may be adjusted in size and flexibility by filling
them with a gas or liquid into the cushions through a sealable
26 orifice communicating through the wall of the cushion.
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WO 01/76403 PCT/[ISIN1/09i29
1 The ocular cushion 26 may be made in a set of multiple
ocular cushions 26 varied in dimensions of both thickness and
width and have variable sized and located ocular apertures 27
therein to best accommodate the size and facial structure of a
va,riety of differing sized individuals using the same helmet
6 casing 12. The chin cushions 28 may also be from a set of such
chin cushions 28 varied in dimensions of both thickness and
width to achieve optimum fit on individual patients. The one
piece facial cushion 31 used with the one piece embodiment of
the helmet casing 12 provides the same adjustable utility and
11 can be varied in the same fashion by providing multiple facial
cushions 31 for use as a kit to be combined with one piece
helmet casing 12. The facial cushion 31 has a facial
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indentation 35 formed on a first side of the facial cushion 31 W
sized to accommodate the face size of the intended patient.
16 The opposite side or exterior surface 38 of the facial cushion
31 would be dimensioned for cooperative engagement with the
interior surface 35 of the one piece embodiment of the casing
12. By varying the dimensions of the cushions 26 and 28 or
31, and the size and location of the apertures therein, and
21 matching them to the properly sized one or two piece helmet
casing 12, virtually any adult or child may be fitted'to wear
the resulting assembled device 10 comfortably with optimal
support of the facial structure of the cranium and maximal
diffusion of pressure and weight about the face and sides of
CA 02404653 2002-10-10
AUG2002
1 The ocular cushion 26 rctay be made in a set of multiple
ocular cushions 26 varied in d.iatensior.`: of both thickness and
width and have variable sized and located ocular apertures 27
therein to best accommodate the size anci facial structure of a
varietv of differing sized individuals using tha same helmet
6 casing 12. The chin cushions 26 may also be from a set of such
chin Cushions 28 varied in dinmensions of both thiclcness and
width to achieve opt imum fit on individiial patients. The one
piece facial cushion 31 used with the one piece embodi.ment of
the helmet casing 12 provides the same adjustable utility and
e
11 can be varied in the same fasilion by providing multipi.e facia:
cu8hions 31 for use as a kit to be combinEd with one piece
hQlmet casing 12_ The facial cushion 31 has afacia'-
indentation 59 fornied on a first side of the facial cushion 31
sized to accommodate the face size of the intended patient.
16 The opposite si.de or exterior surface 38 of the facial cushiois
31 would be dimensioned for coopezative enqagement with the
interior surface 35 of the one piece embodiment. ot the casing
12. By varying the dir-lonsions of the cushions 26 and 28 or
31, and the size and location of the apertures therein, and
21 matching them to the properly sized otze or two piece helne"
casing 12, virtually any adult or child may be ritt'ed to wear
the resulting assembled d vic.e 10 ccmfort3bll with qptirnKl
support of the facial structure of the cranium and maximal
diffus{on of pressure and weight abouf the face and sides of
21
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WO Ol/76403 PCT/[TSO0/09529
When using a disposable form of cushions 26 and 28,and 31
adhesive or other means for a removable attachment can be
placed upon the helmet side of the respective cushion surface
for an easy mount of the cushions into the helmet casing 12
and/or repositionable chin support 14. Such a disposable form
6 of cushions 26, 28, and 31, would be kept sterile inside a
sealed wrapper in the conventional manner and removed and
mounted to the inside face or interior surfaces 35 and 36 of
the helmet casing 12 and chin support 14 respectively as
necessary in the configuration decided upon, using
11 conventional peel and stick adhesive pads positioned upon the
surface of the cushions to attach them to the helmet interior
surface 35.
.The device 10 offers great utility to the user since it w
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is capable of using either disposable or reusable cushions for
16 cushions 26, 28, or 31, or combinations thereof at the
discretion of the professional using the device. Where
disposable cushions are desirable due to their ease of use and
lack of the need for sterilization, just the helmet casing 12
and chin support 14, if used, need be sterilized. Or, in the
21 case of the once piece casing just the casing need be
sterilized if required. However, a reusable form of cushions
26, 28 and 31 may also be used in the device 10 where the
cushions can be sterilized between use, or, in instances where
sterilization is determined not to be needed they need only be
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WO 01/76403 PCT/US00/09529
1 washed. Or, a combination of reusable and disposable cushions
26, 28 and 31 may be used should such be desired or required
if a reusable cushion is lost or damaged.
In use, with the two-piece embodiment, the patient would
be measured for the optimum helmet casing 12 size which would
6 be chosen from a plurality of available interchangeable helmet
casings available, and, a chin support 14 of proper size which
would be chosen from a plurality of interchangeable chin
supports capable of attachment to said casing 12. Also chosen
to accommodate differing facial and head dimensions would be
11 the properly dimensioned cushions 26 and 28, from a set of
interchangeable cushions, to allow the patient maximum comfort
and diffusion of pressure about the surface of the face and
side of the head. The patient could be given samples of the
different sizes of cushions 26 and 28 from a set of variable
0
16 dimensioned cushions 26 and 28 to which the patient would give o
input as to the best possible fit or a medical technician
might also help determine the optimum casing and cushion
dimensions with or without the patient's input. This
availability of an assortment of cushions and assembled helmet
21 sizes allows for a modular system of helmet casings 12 and
attachable chin supports 14 assembled to the helmet, to be
used in conjunction with the desired dimension of cushions 26
and 28, also from a set of such cushions of differing
dimensions, to achieve the optimum fit on a variety of sizes
23
WO 01/76403 PCTIUSOO/09529
1 of patient heads.
Once the optimum dimensions of the cushions 26 and 28 are
determined, yielding a comfortable fit and maximal pressure
distribution about the face and sides of the head, the
cushions 26 and 28 are removably mounted into the interior of
6 both the helmet casing 12 and chin support 14 using the
aforementioned adhesive or fastener cooperating mounts 32
located upon the cushions which attach to cooperating mounts
33 which are positioned upon the helmet casing 12 and chin
support 14 respectively. This is accomplished in a manner to
11 allow for the mounting the cushions 26 and 28 into the
cooperatively configured interior surfaces 35 and 36 of the
helmet casing 12 and chin support 14 respectively.
The inside surface 35 of the helmet casing 12 features a
casing ocular aperture 37 and the chin support 14 has a chin
16 support aperture 39. When properly positioned in the
cooperating inside faces of the helmet casing 12, the aperture
27 in the ocular cushion 26 will be relatively in line with
the casing ocular aperture 37 such that the eyes and nose and
some surrounding portions of the patient's face, or the ocular
21 area of a patient's face, may be easily viewed through the
ocular aperture 37 when the device 10 is being used during
surgery after being positioned upon the patient's face. The
ocular aperture 27 might best be made slightly larger than the
casing ocular aperture 37 to allow for easy mounting of the
24
WO 01/76403 PCTlUSOO/09529
1 ocular cushion 26 into the helmet casing 12 to allow for the
patient's eyes and surrounding skin area to be viewed through
the casing ocular aperture 37 and relatively in-line cushion
ocular aperture 27. Where the casing ocular aperture 37 wraps
around to the side of the helmet casing 12, the in-line ocular
6 cushion aperture 27 would also wrap around in a relatively in-
line position with the casing ocular aperture 37. This in
line relationship of apertures creates a viewing passage
communicating through the helmet casing 12 and apertures 37
and 27 thus revealing the patient's temple area of the head in
11 addition to the ocular area of the face and the nose. This in
line relationship of the apertures of the cushions 26 and 28
with the casing apertures 37 and 29 also allow for the passage
of conventionally used tubes through the in line apertures
into the patient's nose and/or mouth for providing life
16 support during the operation. Further, the cavity formed by
the in line cushions 26 and 28 attached to the helmet casing
12 and chin support 14 gives protection to these tubes at the
critical entry and exit positions on the patient at the nose
and mouth such that the tubes, inside the cavity, will not
21 bend to a point where flow therethrough is interrupted with
possible life threatening consequences to the patient. For
additional utility, optional tube passages 44 communicating a
tubular passageway from the interior of the device 10 to the
exterior, can provide for communication of tubes or sensing
WO 0U76403 PCT/US00/09529
1 device wires therethrough to the patient. Exterior mounted
optional tube positioners 46, of hook and loop fabric or other
type of fastener suited to the job, can be optionally mounted
upon the exterior of the device 10 to hold tubing and/or wires
for monitoring the patient operatively therein during surgery.
6 Snap on fasteners may also be optionally attached at the
exterior of the device 10 to hold tubing and the like. By
providing optional strategically placed snap mounts 48 the
snap on fasteners may be placed in differing positions about
the exterior to hold the tubing and/or wiring required for
11 certain surgical procedures in place and out of harms way.
The chin support aperture 39 of the two-piece embodiment
lines up with the bottom of the casing ocular aperture 37 when
the dismountable chin support 14 is operably mounted to the
helmet casing 12. The chin support aperture 39 allows for
16 viewing and access to the lower mouth area of the face of the
patient with the chin of the patient being supported by the
chin aperture 29 in chin cushion 28 removably attached to the
interior surface 36 of the chin support 14.
Added utility is provided by the device 10 operably
21 mounted to the face of the patient using attributes of the
frontal surface 41 of the device 10. This frontal surface 41
if made flat like that of the upper table surface 64 of a
conventional operating table, allows for a stable support of
the patients face inside the properly mounted device 10 when
26
CA 02404653 2002-10-10
pgnR~00109 5~ 9
WEAAJs 1 s AUG ZaOZ
1 devfce wires therethrauqh to the. patiaeri.t_ Exteriur mounted
optiort.al tuti-P poeitionwrs 46. nr" 'r-ook and loop labric or other
type ot ra9tener Buited to the 7odg can be ont.iorial]y mousited
upan the axterlor of the device 10 to T:bid tl.iyir,y ziedloe. L:ires
.for monitoringf the pntient operatively therein during surgcry.
6 5nap on fa~reners lpay also be opta.onally att,cha-I at the
extericr of the dovica 10 to hold tubing a,nd the li3:n. 9y
providiu.q optional stret glcaily pl$ced scaa<p ;aoun}.s 4e the
eriap on LaatQaers mny be pl$aed in differirig positions about
the exterior to hokd the tubing ancllot wirinq requlreG for
11 certain aurglcrsl procedures in p1.ac-A and out of harms --;:ty-
The chin support apesture 39 of the two-pieCe emboriiment
iinfts up with Cke uotrom of tho ca; ing octilar apert.sre 37) when
the c34srnount:able ch.ln support 14 i5 operably rnouzted to the
:tielmet casing 12. ThP chin guppor.t aperturr 39 al.lawy rcr
16 viewing nnci at;ceas to the lower motiYh ar a of the iucr -. = rne
patient wittl the Ch:c of the pat:.eT1t b2ing supporte;i by Chg
ehir: aperture 39 in chin eu5hivn 29 remo-ably at-:acne:i co the
in=eti<-,r aurrar.e 36 of the chir. support 14.
A3doj t;tility i.s previdec by the scvice 10 op era'a_;
21 mvunced to the face of the paticnt using attribites uC
frontal r:urfac:e 41 of ti,e dev:ce lt-_ This Pront,+l t;ur:ace 41
if macie flat tikn that of the l1F.lpP?:' tacle butEaza 64 :rT -A
cor.ventional operating rsble, a;.lows for a stahe suppc,rt cf
the patiente face inside the pLoperly zaou-nted dev'_oe 10 w:en
Z6
I't.MEND~ SEWr
WO 01/76403 PCT/US00/09529
1 helmet casing 12 above the underlying table surface 64 to
accommodate various posture positions for the patient's head
and neck.
The single piece embodiment of the helmet casing 12
features a front wall surface 41 which extends laterally and
6 then curves to a pair of side walls 47 both of which begin at
one side with their communication with the front wall surface
41 and extend vertically at an acute angle from the front wall
surface 41 to form the two substantially parallel sidewalls
47. In this embodiment the casing ocular aperture 37 in the
11 current best mode, is enlarged and extended around and through
the front wall surface 41 and upward onto and through at least
one side surface 47 of the helmet casing 12 providing a clear
= ,~
view of the patients eye, and face in the temple area, as well W
as the area in front of the nose, from one or both sides of o
N
16 the device 10. Extending the casing ocular aperture 37 and
the cushion ocular aperture 27 up at least one sidewall 47,
whether they are used in combination or when the cushion might
be used by itself, thus provides a means to view the eye
socket and surrounding area through the sidewalls 47 of the
21 device of the patients who might use the device. In the
current best mode, the ocular apertures of both the once piece
helmet casing 12 and the facial cushion 31 extend up both
sidewalls 47 to provide a viewing passage 82 of both eyes and
the surrounding temple area of the head of the patient through
28
WO 01/7G403 PCT/[ISfNI/09529
1 the sidewalls 47. Viewing of the temple area is also achieved
through the transparent material making up the helmet casing
12 and would allow for a larger ocular cushion aperture 27 to
provide more of a view of this area thus allowing even greater
viewing of the patients eye area much like a window.
6 During times of moving of the patient for roll over or
off of the surgical table and onto a gurney, an optional top
handle 40 attached to the top area of the helmet casing 12
portion of the assembled device 10 allows medical personnel a
solid griping point for providing head and neck support to the
11 patient while being rolled over or otherwise moved. By
holding the patient's neck with one hand and the handle 40 in
the other, essential support can be provided to avoid injury
to the anesthetized patient. A roller or ball or other
conventional bearing 42 can also be placed at the base of the
16 handle 40 should easy rotation of the handle 40 be desired
during use. Such a rotation of the handle 40 on the bearing
42 allows for a smooth roll over of the patient with the
patient's neck concurrently supported, thus minimizing
possible neck injuries during roll over and other hazardous
21 patient relocation procedures.
Additional utility in the disclosed apparatus herein is
provided by the insulating factor provided to the patient
wearing the surgical helmet 10 and cushions 26, 28, and 31,
when mounted upon the face of the patient during a surgical
26 procedure. Operating rooms are conventionally kept quite cold
29
WO 01/76403 PCTIUSOO/09529
1 to keep medical personnel and surgeons cool and alert during
surgical procedures. The patient however is generally
unclothed during such procedures and can suffer discomfort
from the overly cool environment of the room. The cushions
26, 28 and 31, form to the face of the patient and are mounted
6 upon the interior surface 35 of the device 10, and thereby
encompass the face and part of the sides and top of the head
of the patient. The result being that the face, sides, and top
of the patient's head are insulated from the cool room
temperature, helping to keep the patient warmer in the
11 unnaturally cool environment of the operating room.
Further utility is also provided by this surgical helmet
device 10 through the use of optional slot passages 45 located
in the face of the device for positioning of tubes therein. During a surgery
requiring the patient to lay face down, tubes
16 providing breathing supplies to the patient may be positioned
in a slot configured to allow the tube to recess therein such
that the tube will not collapse when the patient is face down
and the tube is between the table and casing exterior surface
49 of the device 10. Such a slot passage or multiple slot
21 passages 45 may be positioned about the face of the helmet in
other locations than shown.
Figure 7 depicts a preferred embodiment of the device 10
featuring an exploded view showing the helmet casing 12 of a
one piece or unitary construction. In this embodiment, the
26 casing walls are best constructed of rigid substantially
WO 01/76403 PCT/LIS00/09529
1 transparent material such as plastic in a unitary
construction. This embodiment provides the same desired
support for the chin and face provided by the two-piece
embodiment accomplishing this support with a cooperatively
eng4geable once piece facial cushion 31. This one piece
6 embodiment continues to provide proper chin and face support
by slightly elongating the helmet casing 12 in a one piece
design and combining the ocular cushion 26 and chin cushion 28
into a one piece facial cushion 31 which is dimensioned on the
exterior surface 70 of the facial cushion 31 for cooperative
11 engagement with the interior surface 35 of the helmet casing
12. The facial cushion 31 is dimensioned on the interior
surface 69 to provide a comfortable fit to the face of the
patient for which it is to be used. In use, in essentially
the same manner as the two-piece embodiment, the intended
16 patient would be measured for the optimum facial cushion size
31 which would be chosen from a plurality of available
interchangeable facial cushions 31 available for registered
cooperative engagement with the one piece helmet casing 12.
In many cases only one or two different sized helmet
21 casings 12 would be needed in inventory to be mated with
cushions to accommodate a very large number of differently
dimensioned facial cushions 31 since the size, thickness, and
exterior and interior dimensions of the facial cushion 31 may
be varied to accommodate the different facial dimensions of
31
WO Q1/76403 PCT/IIS0bK19529
1 different patients. This is accomplished by the variance of
the dimensions of the indentations 68 formed on the interior
surface 69 of the facial cushion 31 which are used accommodate
the facial dimensions of the intended patient. The exterior
surface 70 of the facial cushion 31 would be dimensioned for
6 operative cooperative engagement with the shape and dimensions
of the interior surface 35 of the helmet casing 12 in the
aforementioned registered and cooperative engagement therein.
The registration and cooperative operative engagement
between the cushion 31 and helmet casing 12 would be
11 maintained using a means for registered engagement of the
facial cushion 31 with the helmet casing 12 which includes
ro
one, or a combination, of registration means, from a group of
Ln
such registration means consisting of frictional engagement
between the interior surface 35 of the helmet casing 12 and IL
16 exterior surface 70 of the facial cushion 31, adhesive 65, a 0
lip 71 located about the upper exterior surface 70 of the
facial cushion 31 in a position to cooperatively engage the
upper edge 75 of the sidewalls 47 of the helmet casing 12, or,
registration pins 73 attached to the body of the facial
21 cushion 31 in positions to cooperatively engage registration
apertures in the casing, in this case axial passages 77 formed
into the legs 60 and sized to accept the registration pins 73
in a removable cooperative engagement. Since the registration
pins 73 would in the current best mode be molded of the same
32
WO 01/76403 PCT/USQQ/09529
1 flexible foam as the facial cushion 31 they offer the current
best mode of registration since the registration pins 73 will
compress during insertion into the axial passages 77 and then
naturally bias against such compression into removable biased
frictional engagement with the interior of the axial passages
6 77. While the aforementioned are the current best mode of a
registration means between the facial cushion 31 and the
helmet casing 12, those skilled in the art may devise other
such means of registered engagement and such are anticipated.
In fitting the patient for maximum comfort and support,
11 the patient could be given samples of the differently
dimensioned facial cushions 31 from an available plurality or
set of variably dimensioned facial cushions 31 to which the
patient would give input as to which formed indentations 68
provide the best possible fit to the facial dimension of the
16 patient. Or, a medical technician might also help determine
the optimum helmet casing 12 and facial cushion 31 dimensions
with or without the patient's input. This availability of an
assortment of differently dimensioned facial cushions 31 to
cooperatively and operatively engage one or a plurality of
21 helmet casings 12, allows for a kit or modular system of
helmet casings 12 and attachable to facial cushions 31 to
achieve the optimum fit on a variety of sizes of patient
heads. For easy identification of size the facial cushions 31
would be marked with appropriate indicia 30 in writing showing
33
WO ul/7f403 PCT/[ISIN1/09529
I a size designation or in the best current mode with indica in
the form of color coding for easy identification. The color
coding or written indica 30 to identify size could be imparted
by extruding it in the color of the foam making up the facial
cushion 31 or silkscreened or otherwise applied on the surface
6 of the cushions 26, 28, and 31. Once the optimum dimensions
of the facial cushion 31 are determined, yielding a
comfortable fit and maximal pressure distribution about the
face and sides of the patient's head, the facial cushion 31 is
removably mounted to the interior of the helmet casing 12
11 using the aforementioned means for registered engagement of
the facial cushion 31 with the helmet casing 12.
The one piece facial cushion 31 offers an additional
benefit in that in some cases it might be used without the w
helmet casing 12. Use without the casing might occur when an
16 especially low mount of the patient's head is desired for
posture or for the surgical procedure, or, in an emergency or
other situation where the additional support and utility of
the in-line helmet casing 12 is not required. Use of the
facial cushion 31 by itself, while not offering the full
21 utility of the best mode in combination with the helmet casing
12, does provide the easy side viewing of the patients eyes
through the elongated ocular cushion aperture 27 and still
provides improved support and padding to the patient's head
during surgery. Consequently, it is anticipated that the
34
WO 01176403 PCT/LTS00l09529
1 cushion might be used alone without the casing 12, and while
not providing all of the utility of the device featuring the
combination of the facial cushion 31 with the helmet casing
12, using the cushion alone would still provide much better
support to the patient's face, a clear view of the eyes
6 through the elongated cushion ocular aperture 27 and a solid
support to the patient's head on the table through frictional
engagement therewith.
Or, in some cases, where reuse of the cushion may not be
advisable due to the patient, the helmet casing 12 might also
11 be formed into the exterior of the facial cushion 31 itself.
This could be done if a substantially rigid shell 80 were
formed about the exterior surface 70 of the facial cushion 31
by either lamination thereto or in the molding process and
would provide rigid support to the facial cushion 31. However
16 this configuration with the helmet casing 12 as attached to
the facial cushion 31 as a laminated or permanent shell yields
less utility in that different facial cushions 31 for
different sized patients could not be matched to a single
helmet casing 12 thus requiring more stock of product. But,
21 differing user criteria and requirements may call for the
facial cushion 31 to be thus used and manufactured with a
casing formed by the rigid shell 80 formed on the outside
surface for use without the additional advantages afforded by
mating with the helmet casing 12 and such is anticipated.
WO Ot/76403 PCT/[IS00/09529
1 While the current best mode of the device, affording the most
utility, is the registered engagement of a properly sized
facial cushion 31 with the helmet casing 12, the cushion-only
embodiments offer the operating staff the option to use the
facial cushion 31 without the helmet casing 12 and still
6 achieve much better support of the patient's head, thermal
insulation and view of the patient's eye and surrounding
temple area 74 which is a marked improvement to the current
practice of placing the head on a towel. The very nature of
the exterior surface 70 of the soft foam facial cushion 31
11 would provide a good frictional mount to the surface of the
table surface 64 and good side and frontal support to the head
of the patient with a concurrent view through the elongated
casing ocular aperture 37 reaching around the side to allow a
view of the patient's eye socket from an operative distance.
16 Use of the facial cushion 31 could also occur if there were a
shortage of helmet casings 12 for the number of patients
requiring surgery during an emergency situation. Consequently
it is anticipated that the facial cushion 31 could be used by
itself in certain instances and would still be a substantial
21 improvement for a mount and support of the patient's head than
the present art.
To provide an excellent view of the patient's facial
features, as with the two piece embodiment, the interior
surface 35 of helmet casing 12 features a casing ocular
26 aperture 37 communicating through the casing front wall 41
36
WO 01/76403 PCT/[IS00/09529
1 surface and side walls 47 and the chin support aperture 39
formed into the front wall 41 surface and communicating
therethrough. The one piece embodiment the helmet casing 12 as
noted also features an elongated casing ocular aperture 37
which wraps around the helmet casing 12 to determined
6 termination points in one or both substantially parallel side
walls 47, and thus allow for easy viewing of the eye area of
the patient during use by looking through the in line casing
ocular aperture 37 and cushion ocular aperture 27. In the one
piece embodiment this casing ocular aperture c communicates
11 with the chin support aperture 39 to yield a somewhat figure
eight shaped aperture when the casing is viewed from the
bottom. The in line ocular cushion ocular aperture 27 where
it intersects the cushion chin support aperture 39, yield a
nasal cavity 57 the area of which is defined by the thickness
16 of the wall surface of the facial cushion 31 and the perimeter
of the intersecting chin support aperture 39 and the cushion
ocular aperture 27. Along with providing a passageway for
tubes to the patient, the nose cavity 57 also yields a good
view of the nose and facial area around the nose when the
21 patent is in the prone position, providing additional utility
to the device. I
When properly positioned, the cooperating engagement of
the facial cushion 31 and helmet casing 12, will place the
cushion ocular aperture 27 substantially in line in a
37
CA 02404653 2002-10-10
_ . .. -. . ~ - .
MUS 1 s AU G Zoo2
1 surface and side wa17.s 47 and the chin support aperture 39
formECl into the front wall 41 surface and communicating
therethrough. The one piece embodi.ment the helmet casing 12 as
noted also features an elongated casing ocular aperture 37
which-wraps around the helmet casing 12 to determined
6 termination points in one or both substantially parallel side
walls 47, and thus allow for easy viewing ot the eye area of
the patient during use by looking through the in line casing
ocular aperture 37 and cushion ocular aperture 27. In the one
piece einhodiment this casing ocular apertAt're 37 communicates
11 with the chin support aperture 29 to yield a sotnewhat figure
eight shaped aperture when the casi.ng is viewed from the
bottom_ The in line ocular cushi.on ocular aperture 27 where
it intezsects the cushion chin guppcrt apertux-e 39, yield a
nose cavity 57 the area of which is defined by the thir.kness of
16 the wall surface of the facial cushion 31 and Lhe perimete: of
the inter sec-Cirig cnin support aperture 39 a.'td ti~t, cushion
ocular aperture 27. Alonq with providing a pa~:sageway for
tubes to the patient, the nose cavity 57 also .ylelds a good
view of the nose and facial area around the nose WhFn the
21 patent=is in the prone posation, providing additional utility
to the device.
When properly positioned, the cooperating engagement of
the facial cuthion 31 and hel.met casing 12, will place the
cushion ocular aperture 27 substantial? v in l.itYe in a
38
AIvIEMED SPIMM
_ .. . ...~..-,
WO 01/76403 PCT/US00/09529
1 forming the viewing passage communicating through the helmet
casing 12 and the apertures in the facial cushion 31 providing
an excellent view of the patient's temple area of the head in
addition to the ocular area of the face and a nose cavity 57
for accommodating and viewing the nose from both sides of the
6 device and well as from below the device when mounted on the
operating table. This in-line relationship of the cushion
apertures 27 and 39 with the casing apertures 37 and 29 also
allows for the passage of conventionally used tubes through the
in line apertures into the patient's nose and/or mouth for
11 providing life support during the operation.
Figure 8 depicts the facial cushion 31 inserted and
registered in position with the helmet casing 12 which is in a
registered position removably attached to an optional mount
plate 66 using couplings 62 configured to cooperatively engage
16 the distal ends of the legs 60 which are attached to the helmet
casing 12 at their opposite ends. The couplings 62 are depicted
as pins that insert into indents in the legs 60 but this
arrangement could be reversed with the legs positionable into
indents in the mounting plate 66 or other means for attachment
21 of the legs 60 to the couplings 62 could be used and are
anticipated. If needed to adjust the height of the helmet
casing 12, and thus the height of the head of the patient for
comfort or function, one or a plurality of leg extensions 61
may be used to adjust the height as desired. The leg extensions
39
WO 01/76403 PCT/US00/09529
1 61 would of course be configured to operatively engage in a fit
between the legs 60 and the couplings 62.
The couplings 62 alone using adhesive or other manner of.
attachment could be pre-installed to the operating table
surface 64 in cases where the optional mounting plate 66 is not
6 desired, however in the current best mode, the mounting plate
66 positioned on the operating table surface 64 would provide
the couplings 62 attached in positions to cooperatively engage
the distal end of the legs 60 to thereby provide a stable means
of elevated attachment of the helmet casing 12 above the table
11 surface 64 in registered engagement with the mounting plate 66.
By the provision of a means for elevation, through the
provision of legs 60 to slightly elevate the helmet casing 12
above the operating table surface 64, and the means for
elevation adjustment using the leg extensions 61, or other
16 manner of extending the length of the legs 60 such as
telescopic legs, or legs extending with pins to hold the
elongation of the legs, better patient posture is achieved by
keeping the patient's neck in line. Elevating the helmet
casing 12 and patient therein also elevates the casing ocular
21 aperture 37 and casing chin aperture 29 thereby allowing better
views therethrough of the patient for direct viewing by the
staff. The casing ocular aperture 37 being extended around the
frontal area and communicating between the casing interior
surface 35 and casing exterior surface 49 and extending to the
WO 01/76403 PCT/[IS00/09529
1 side area of the helmet casing 12, provides an easy and clear
view of the patients eye and temple area 74. For additional
utility, the aforementioned optional tube passages 44 could be
operatively positioned in the once piece embodiment of the
helmet casing 12 to provide a tubular passageway from the
6 interior of the device 10 to the exterior for the various
devices requiring such.
While elevating the helmet casing 12 provides extra room
between the table and the in-line apertures to allow better
viewing of the patient from the side and below, in the current
11 best mode, the placement of a mirrored surface 72 on the upper
surface 67 of the mounting plate 66 provides additional utility
through the provision of a means for the upright operating
staff to view of the patients eyes and temple area around the
eye, through the in line ocular and chin apertures 29 and 37. N
16 Normally the doctor or staff member wishing to view the 10
patient's eyes area adjacent to the eye temple area 74 or face
would have to stoop to an angle wherein they can be seen
through the in line apertures in the helmet casing 12 from the
side, or in some cases from below the operating table.
21 However, with the provision of a mirrored surface 72,
operatively placed on the upper surface 67 of the mounting
plate 66, the doctors and staff are afforded a means for a
continuous real time view while standing, of the patient's eyes
and mouth through the apertures 37 and 29 in the helmet casing
41
WO 01/76403 PCT/IISOO/09529
1 12. Should even more adjustability of the reflection be
desired so that certain staff in certain positions can see the
patient's eyes and mouth, a means for angular adjustment of the
mirrored surface 72 could be attached between the mounting
plate 66 and the mirrored surface 72 such as a ratchet 78 or
6 other conventional means for angular adjustment that will
provide the user with the ability to adjust the angle of the
mirrored surface 72 from substantially parallel to the mounting
plate 66 toward a position normal to the mounting plate 66.
The mirrored surface 72 with the means for angular adjustment
11 thus may be positioned to an infinite number of angles between
positions parallel and normal to the mounting plate 66. Such
adjustment provides substantial utility to the operating room A
0
A
staff and doctors by allowing them to adjust the mirrored W
surface 72 to obtain the best possible view of the patient N
16 through the in line apertures of the facial cushion 31 and
helmet casing 12.
Should additional enhancement of patient viewing be
desired, the addition of the optional illumination means in the
current best mode in the form of light 76 which further
21 enhances the reflected view in the mirrored surface 72 by
illumination of the patient's facial features which reflect in
the mirrored surface 72. The illumination means could be a
conventional light bulb, a light emitting diode, or other
similar light sources and can be powered by conventional AC or
42
WO 01/96403 PCT/IJSOO/09529
1 battery power that is readily available in the operating arena.
Construction of the one piece embodiment of the facial
cushion 31 and the various options thereto, is best depicted in
figure 9 and Figure 10. As shown from the top perspective view
of figure 9, the indentations 68 to accommodate various sized
6 faces and facial structures are operatively positioned and
provide excellent head support in the form of a forehead
support 54, cheek supports 55 and chin support 56. The
registration pins 73 protrude from the exterior surface 70 in
positions to register the facial cushion 31 in operative
11 engagement with the leg axial passages 77 extending axially
through the legs 60 of the one piece embodiment of the helmet
casing 12. Registered insertion of the facial cushion 31 into
the helmet casing 12 is thus easily achieved by the in line
cooperative engagement of the registration pins 73 with the
16 axial passages 77 in the legs 60. Of course the other
aforementioned means of registration of the facial cushion 31
with the helmet casing 12 might also be used including the lip
71, adhesive 65, or frictional engagement of the exterior
surface 70 of the facial cushion 31 with the interior surface
21 of the helmet casing 12. In cases where the additional utility
of the helmet casing 12 encompassing the facial cushion 31 is
not required the facial cushion 31 could be used alone in a
frictional engagement with the surface of the table surface 64.
43
WO 01/76403 PCT/[ISOO/09529
1 Figures 11 and 12 provides a bottom perspective view and a
top perspective view respectively, of the one piece embodiment
of the helmet casing 12_ As shown, the legs 60 contain the
axial passageway 77 therein communicating with an leg aperture
63 at each end for registered engagement of the molded
6 registration pins 73. The elongated casing ocular aperture 37
in the one piece casing extends across the bottom and up both
sides of the one piece helmet casing 12, and communicates with
the chin aperture 29 to form a single large "t" or figure eight
shaped aperture which registers in an in-line relationship with
11 a similar shaped and slightly larger aperture in the one piece
facial cushion 31. Also depicted are a pair of optional tube
passageways 50 providing communication to the interior of the
helmet casing 12 through axial tube passages 52 therein. w
A preferred embodiment of the mounting plate 66 component N
16 is depicted in figures 13 and 14_ The mounting plate 66 in the to
current best embodiment is constructed of rigid plastic such as
polycarbonate,which is substantially transparent. A plurality
of couplings 62 are attached to the upper surface 67 of the
mounting plate 66 to provide the registered mount for the legs
21 60 of the helmet casing 12. In this embodiment, rather than
having the mirrored surface 72 on the upper surface 67 of the
mounting plate 66 the mirrored surface 72 is adhered to the
bottom surface 83 of the mounting plate 66. Adhering the
mirrored surface 72 to the mounting plate bottom surface 83
44
WO 01/76403 PCT/USbO/09529
1 facing upward toward the tope surface, allows the mirrored
surface 72 to provide the desired reflection of the patients
face through the substantially transparent plastic material of
the mounting plate 66 while concurrently protecting the
mirrored surface 72 from scratching. In this embodiment the
6 mirrored surface 72 may be adhered to the bottom of the
mounting plate 66 by using mirror attached into an indent in
the bottom surface 83 or by applique of a metalized or
reflective surface to the bottom surface 83 such that when
viewed through the substantially transparent material making up
11 the mounting plate 66 from the upper surface 67 a reflection is
provided. The depicted optional outwardly biased conventional
plunger ball 85 would provide additional stability to the
tn
couplings 62 in their cooperating engagement with the legs 60.
Additional utility during procedures where the temperature
16 of the patient is a concern is provided by the optional
removably attachable means for heating the head of the patient.
In the current best embodiment the means for heating the head
of the patient is provided by a removably attachable heating
blanket 87 as depicted in figure 15. The heating blanket is
21 removably attachable to the helmet casing 12 using biased clip
90 which is spring loaded and attaches to an upper edge of the
helmet casing 12. The heating blanket 87 provides heat using a
resistive element 92 which heats the blanket body 93 when power
from an electrical power source 94 is communicated thereto
WO 01/76~103 PCT/USOb/09i29
1 through conventional wires 96. The heat is distributed evenly
by the serpentine arrangement of the resistive element 92 thus
avoiding hot spots. Control of the amount and duration of heat
would be provided by a conventional thermostat 98 engagement
with'the resistive element 92 to break the circuit when the
6 desired temperature is obtained. The wires 96 might also be a
flat strip style wire that is appliqued to the exterior surface
70 of the helmet casing 12 and an interface on the clip 90 such
that attaching the clip 90 to the helmet casing 12 would also
provide power to the blanket 87 through the interface in the
11 clip 90. Alternatively, in some cases it may be more
advantageous to attach the resistive element 92 by affixing it
or appliqueing it to the interior surface of the helmet casing
12 in between the facial cushion 31 and the helmet casing 12
where it would work in the aforementioned fashion but provide
16 heat to the face of a prone patient or the back of the head of
a supine patent using the disclosed device.
While all of the fundamental characteristics and features
of the protective cushion and cooperatively engageable helmet
casing for anesthetized patient have been shown and described,
21 it should be understood that various substitutions,
modifications, and variations may be made by those skilled in
the art without departing from the spirit or scope of the
invention. Consequently, all such modifications and variations
are included within the scope of the invention as defined by
26 the following claims.
46
